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R E 1 Assessment of environmental risks of biocides - focus on emission scenarios EU course on Environmental Exposure Scenarios in Risk Assessment.

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Presentation on theme: "R E 1 Assessment of environmental risks of biocides - focus on emission scenarios EU course on Environmental Exposure Scenarios in Risk Assessment."— Presentation transcript:

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2 R E 1 Assessment of environmental risks of biocides - focus on emission scenarios EU course on Environmental Exposure Scenarios in Risk Assessment

3 Environmental risks of biocides | Peter van der Zandt & Paul van der Poel r 2 EU Regulations and Directives new chemicalsEC Directive 67/548/EEC existing chemicalsEC Council Reg. 793/93 pesticidesEC Directives 91/414/EEC biocidesEC Directive 98/8/EEC veterinary drugsEC Regulation 2377/90 feed additives EC Directive 70/524/EEC food additives89/107/EEC cosmeticsSCP/803/90 packaging materialEC Directive CS/PM/1025

4 Environmental risks of biocides | Peter van der Zandt & Paul van der Poel r 3 Elements of Chemicals Control Data collection and exchange of information Classification and labelling Risk assessment Risk management (a.o. authorisation)

5 Environmental risks of biocides | Peter van der Zandt & Paul van der Poel r 4 The EU Biocidal Products Directive (1998) ñ Why ? :Risk Management ! Whereas 1:.. 1993.. Council.. need for risk management of non- agricultural pesticides.. ñ How ? (1): Authorisation procedure Whereas 4:.. rules for placing on the market.. taking as a condition a high level of protection for humans, animals and the environment.. ñ How ? (2): Risk Assessment Whereas 7, 8, 9, 11; Article 5; Annex VI TGDs: data requirements, risk assessment of active substances,...

6 Environmental risks of biocides | Peter van der Zandt & Paul van der Poel r 5 Environmental Risk Assessment: Basic Framework PEC/PNEC Risk characterization Data set Data evaluation Single species toxicity data Extrapolation PNEC Effects assessment Emissions Distribution PEC Exposure assessment EUSES TGD

7 Environmental risks of biocides | Peter van der Zandt & Paul van der Poel r 6 Life cycle Life cycle PRODUCTION FORMULATION SERVICE LIFE PRIVATE USE INDUSTRIAL USE In product Processing aid WASTE DISPOSAL - Incineration -Landfilling - Recovery Processing aid

8 Environmental risks of biocides | Peter van der Zandt & Paul van der Poel r 7 STP Grassland Agricultural soil Surface water Sediment Groundwater Air Deposition Leaching Sedimentation Dilution Sludge application Volatilization Local emissions Local emission and distribution routes

9 Environmental risks of biocides | Peter van der Zandt & Paul van der Poel r 8 Indicative food chains fish PREDATORS SOIL POREWATER SURFACE WATER earthworm

10 Environmental risks of biocides | Peter van der Zandt & Paul van der Poel r 9 Exposure assessment (results) Protection targetPEC __________________________________________ micro-organismsSTP effluent aquatic organismssurface water terrestrial organismsagricultural soil sediment organismssediment predatorsfish or earthworms __________________________________________

11 Environmental risks of biocides | Peter van der Zandt & Paul van der Poel r 10 Effects assessment laboratory testing (single species; standardised test) various trophic levels algae + + crustacea fish Aquatic ecosystem ?

12 Environmental risks of biocides | Peter van der Zandt & Paul van der Poel r 11 PNEC derivation (water) Data Assessment factor Short-term L(E)C 50 from each of three trophic levels of1000 the base-set (fish, daphnia, algae) One long-term NOEC (either fish or Daphnia) 100 Two long-term NOECs from species representing two 50 trophic levels (fish and/or Daphnia and/or algae) Long-term NOECs from at least three species representing 10 three trophic levels (normally fish, Dapnia, algae) Field data or model ecosystems case by case

13 Environmental risks of biocides | Peter van der Zandt & Paul van der Poel r 12 EU TGD: importance of emission estimation The TGDs were to be revised, and to also incorporate aspects which are specific for risk assessment of biocides For biocides, the addition of specific emission and exposure scenarios had a high priority (Biocides TM, 1999) ñwhy ? –uses are the most prominent difference with other chemicals –emission has most significant influence on the final outcome of risk assessment

14 Environmental risks of biocides | Peter van der Zandt & Paul van der Poel r 13 Experience of initial vs. refined RAs UncertaintyFactor __________________________________________ PNEC± 10 emission rates10 - > 1000 STP emission estimation< 10 biodegradation in surface water< 10 exposure assessment PEC10 - > 10,000 __________________________________________

15 Environmental risks of biocides | Peter van der Zandt & Paul van der Poel r 14 Emission Scearison

16 Environmental risks of biocides | Peter van der Zandt & Paul van der Poel r 15 Definition of ESD An Environmental Emission Scenario Document is: A set of conditions about sources, pathways, production processes and use patterns that quantify the emissions (or releases) of a chemical from production, formulation, processing, private use (or use in the household) and recovery/disposal into water, air and solid waste (OECD 2000) In general, an ESD should cover all aspects of the life-cycle. An ESD may cover only some parts of the life-cycle, if remaining parts are not relevant or covered by another ESD.

17 Environmental risks of biocides | Peter van der Zandt & Paul van der Poel r 16 Life Cycle & Risk Assessment PRODUCTION FORMULATION APPLICATION SERVICE LIFE WASTE New & Existing Substances Biocidal Products Directive Local & RegionalScale LocalScale

18 Environmental risks of biocides | Peter van der Zandt & Paul van der Poel r 17 Local scale (1 point source for each life cycle stage) Process Next stage of life cycleAIR 100 m WastewaterSTP SOIL

19 Environmental risks of biocides | Peter van der Zandt & Paul van der Poel r 18 P P F F F I I I I I I I I I I II I I Regional scale (all sources all stages of l.c.) all stages of l.c.) Production Production Formulation Formulation Industrial use Industrial use

20 Environmental risks of biocides | Peter van der Zandt & Paul van der Poel r 19Process Quantity of product Quantity of product Content in product Content in product Emission factor(s) Emission factor(s) Industrial category Industrial category Function of substances Function of substances Factors of Importance

21 Environmental risks of biocides | Peter van der Zandt & Paul van der Poel r 20 Concept of Emission Estimation Elements: Description of the industry or use area (process)Description of the industry or use area (process) Description of the types of substances used and their function in the industry areaDescription of the types of substances used and their function in the industry area Identification of points of release and emission factorsIdentification of points of release and emission factors Information on the scale/size of operationsInformation on the scale/size of operations Information on emission control measuresInformation on emission control measures Instruction on how to use the information in ESDInstruction on how to use the information in ESD and examples of calculations

22 Environmental risks of biocides | Peter van der Zandt & Paul van der Poel r 21 Emission = Q * Fms * EF / Tem * 10 -3 (kg.d -1 ) Emission Scenario 1: Tonnage of Substance EFEmission factor (-) TemNumber of emission days (d.yr -1 ) Main Source Tonnage WaterAir SoilWaste Emissionfactors No. of days INPUT: INPUT: QTonnage (tonnes.yr -1 ) FmsFraction of the main source (-)

23 Environmental risks of biocides | Peter van der Zandt & Paul van der Poel r 22 Emission = Qp * Qs * EF (kg.d -1 ) Emission Scenario 2: Scale of Process INPUT: INPUT: QpTonnage of product (tonnes.d -1 ) QpTonnage of product (tonnes.d -1 ) QsQuantity of substance (kg.tonne -1 product) QsQuantity of substance (kg.tonne -1 product) EFEmission factor (-) EFEmission factor (-) Emission Factor

24 Environmental risks of biocides | Peter van der Zandt & Paul van der Poel r 23 Emission Scenario 3: Average consumption Emission = Qi * Ni * Fpc * Cs * EF (kg.d -1 ) INPUT: QiConsumption per inhabitant (l.d -1 ) CsContent of the substance in product (kg.l -1 ) FpcFraction of product with substance (-) EFEmission factor (-) NiNumber of inhabitants (-)

25 Environmental risks of biocides | Peter van der Zandt & Paul van der Poel r 24 New & Existing substances Biocides New & Existing substances Biocides A Biocide is a new or existing substance A Biocide is a new or existing substance but but a new or existing substance is not (always) a biocide a new or existing substance is not (always) a biocide A Biocide has a specific function : A Biocide has a specific function : Disinfectant Disinfectant Preservative Preservative Insecticide, acaricide, avicide, piscicide,... Insecticide, acaricide, avicide, piscicide,...

26 Environmental risks of biocides | Peter van der Zandt & Paul van der Poel r 25 Biocidal Products Directive 98/8/EG Annex V 23 biocidal product types Biocides (Use Category 39)

27 Environmental risks of biocides | Peter van der Zandt & Paul van der Poel r 26 EU Biocidal Products Directive 23 Product Types divided over 4 Groups: I DISINFECTANTS & GENERAL BIOCIDES IIPRESERVATIVES IIIPEST CONTROL PRODUCTS IVOTHER BIOCIDES

28 Environmental risks of biocides | Peter van der Zandt & Paul van der Poel r 27 1Human hygiene biocidal products 2Private & public-health area disinfectants and other biocidal products 3Veterinary hygiene biocidal products 4Food and feeding area disinfectants 5Drinking water disinfectants I DISINFECTANTS & GENERAL BIOCIDES

29 Environmental risks of biocides | Peter van der Zandt & Paul van der Poel r 28 6In-can preservatives 7Film preservatives 8Wood preservatives 9Fibre, leather, rubber and polymerised materials preservatives 10Masonry preservatives 11Preservatives for liquid cooling and processing systems 12Slimicides 13Metalworking-fluid preservatives IIPRESERVATIVES

30 Environmental risks of biocides | Peter van der Zandt & Paul van der Poel r 29 14Rodenticides 15Avicides 16Molluscicides 17Piscicides 18Insecticides, acaricides & products to control other arthropod species 19Repellents and attractants IIIPEST CONTROL PRODUCTS

31 Environmental risks of biocides | Peter van der Zandt & Paul van der Poel r 30 20 Preservatives for food or feedstocks 21Antifouling products 22Embalming and taxidermist fluids IVOTHER BIOCIDES 23Control of other vertabrates

32 Environmental risks of biocides | Peter van der Zandt & Paul van der Poel r 31 Example 1 Example 1 Pt 1 : Human Hygiene Biocidal Products PRODUCTION FORMULATION PRIVATE USE SERVICE LIFE WASTE For example: Deodorants, antiperspirants Deodorants, antiperspirants Anti-dandruff shampoo Anti-dandruff shampoo Antimicrobial soap Antimicrobial soapEtc. Skin application Skin application Short term Short term Bathing Bathing

33 Environmental risks of biocides | Peter van der Zandt & Paul van der Poel r 32 Example 1 Pt 1 : Human Hygiene Biocidal Products Example 1 Pt 1 : Human Hygiene Biocidal Products Emission Scenarios of New & Existing Substances a) Tonnage b) Average consumption per inhabitant

34 Environmental risks of biocides | Peter van der Zandt & Paul van der Poel r 33 Example 2 Example 2 Pt 3 : Veterinary Hygiene Biocidal Products 3.1Disinfection of animal housing 3.2Disinfection of footwear and animalsfeet 3.3Disinfection of milk extraction systems 3.4Disinfection of means of transport 3.5Disinfection of hatcheries 3.6Disinfection of fishfarms

35 Environmental risks of biocides | Peter van der Zandt & Paul van der Poel r 34 PRODUCTION FORMULATION APPLICATION SERVICE LIFE WASTE Example 2 Disinfection of animal housing Example 2 Disinfection of animal housing

36 Environmental risks of biocides | Peter van der Zandt & Paul van der Poel r 35 Moment of manuring Example 2 Disinfection of animal housing Example 2 Disinfection of animal housing No. of cows Time Maximum per ha N / P 2 O 5

37 Environmental risks of biocides | Peter van der Zandt & Paul van der Poel r 36 The EUBEES projects In 1999, a number of EU Member States, the European Chemicals Bureau and the European chemical industry (CEFIC), and supported by the European Commission, set up the EUBEES working group to develop environmental emission scenarios for environmental risk assessment of biocides in the framework of the Biocidal Products Directive. EUBEES EUBEES 1 project: January 2000 until June 2001 EUBEES 2 project: January 2002 until November 2003

38 Environmental risks of biocides | Peter van der Zandt & Paul van der Poel r 37 EUBEES 1: Results (1) Report Development of emission scenario documents for 23 product groups of the EU biocidal products directive 98/8/EG, INFU/UBA, D. Emission scenario document for product type 2: private and public health area disinfectants and other biocidal products (sanitary and medical sector), RIVM, NL. Emission scenario document for biocides used in paper coating and finishing (product type 6,7&9), INERIS, F. Emission scenario document for biocides used as preservatives in the leather industry (product type 9), INERIS, F.

39 Environmental risks of biocides | Peter van der Zandt & Paul van der Poel r 38 EUBEES 1: Results (2) Emission scenario document for biocides used as preservatives in the textile processing industry (product type 9&18), INERIS, F. Emission scenario document for biocides used in taxidermist and embalming processes (product type 22), INERIS, F. Report Proposal for the formats of names, parameters, variables, units and symbols to be used in emission scenario documents, RIVM, NL.

40 Environmental risks of biocides | Peter van der Zandt & Paul van der Poel r 39 EUBEES 2: objectives and results (1) 1Development of harmonised ESDs: PT 11: preservatives liquid cooling & processing PT 12: slimicides PT 13: metal working fluid preservatives [PT 21: antifouling products (in OECD)] 2Check ESDs for existing substances on their suitability for biocides: PT 1: human hygiene biocidal products PT 6: in-can preservatives PT 7: film preservatives PT 9: fibre, leather, rubber, polymerised material pres.

41 Environmental risks of biocides | Peter van der Zandt & Paul van der Poel r 40 EUBEES 2: objectives and results (2) 3Provide a framework for EU discussion and agreement of new ESDs developed by the members, eg.: PT 5: drinking water disinfectants PT 10: masonry preservatives PT 14: rodenticides PT 18: insecticides (in stables and manure) 4Test the scenarios for wood preservatives developed by OECD and rodenticides developed by the Nordics in the framework of EUBEES, primarily with regard to usability.

42 Environmental risks of biocides | Peter van der Zandt & Paul van der Poel r 41 OECD ESD on antifouling products Antifoulants: inhibit growth of organisms on ship hulls, fishing nets, marine structures. (several definitions!) Aim: OECD-wide harmonisation of available emission scenarios for anti-fouling applications. Most antifoulings, ie. 95% are used on ship hulls. Almost all available scenarios deal with the estimation of releases of antifoulings during the service life. The EESAF steering group will have its third meeting in November 2003. The draft ESD is intended to be finalised early 2004 and submitted to the OECD JM end 2004.

43 Environmental risks of biocides | Peter van der Zandt & Paul van der Poel r 42 ESDs for Main Group 1 (disinfectants) PT 01: Human hygiene biocidal products (RIVM, EUBEES2) PT 02: Private and public health area disinfectants –Medical equipment (EU) –Accomodation (RIVM) –Industrial areas –Swimming pools (RIVM) –Air-conditioning –Chemical toilets –Wastewater treatment (RIVM) –Hospital waste

44 Environmental risks of biocides | Peter van der Zandt & Paul van der Poel r 43 ESDs for Main Group 1 (disinfectants) PT 03: Veterinary hygiene biocidal products ( ) (RIVM) PT 04: Food and feed area disinfectants PT 05: Drinking water disinfectants ( ) (UBA EUBEES 2 CA) EUBEES

45 Environmental risks of biocides | Peter van der Zandt & Paul van der Poel r 44 ESDs for Main Group 2 (preservatives) PT 07: Film preservatives –Paints & coatings (PT 06) –Plastics (PT 09) –Glues & adhesives (RIVM) –Paper & cardboard (RIVM) PT 08: Wood preservatives (OECD)

46 Environmental risks of biocides | Peter van der Zandt & Paul van der Poel r 45 ESDs for Main Group 2 (preservatives) PT 09: Fibre, leather, rubber & polymer pres. –Textiles & fabrics (EU) –Leather & hides (EU) –Paper & cardboard (EU) –Rubber, polymers, etc. PT 10: Masonry preservatives ( ) (EUBEES 2 CA)

47 Environmental risks of biocides | Peter van der Zandt & Paul van der Poel r 46 ESDs for Main Group 2 (preservatives) PT 11: Preservatives for liquid cooling & processing systems –Cooling systems ( ) (EUBEES 2 CA) –Processing water & liquids PT 12: Slimicides –Paper & pulp ( ) (EUBEES 2 TM) –Mineral oil extraction ( ) (EUBEES 2 TM) PT 13: Metalworking-fluid preservatives ( ) (EUBEES 2 CA)

48 Environmental risks of biocides | Peter van der Zandt & Paul van der Poel r 47 ESDs for Main Group 3 (pest control) PT 14: Rodenticides ( ) (DK EUBEES 2 CA) PT 15: Avicides ( ) (F EUBEES 2 TM) PT 16: Molluscicides PT 17: Piscicides E = c pond

49 Environmental risks of biocides | Peter van der Zandt & Paul van der Poel r 48 ESDs for Main Group 3 (pest control) PT 18: Insecticides, acaricides and products to control other arthropods –Manure & stables ( ) (RIVM) –Refuse dumps –Fumigants (RIVM) PT 19: Repellents and attractants

50 Environmental risks of biocides | Peter van der Zandt & Paul van der Poel r 49 ESDs for Main Group 4 (other products) PT 20: Preservatives for food & feedstocks PT 21: Antifouling products ( ) ongoing PT 22: Embalming and taxidermist fluids (EU) PT 23: Control of other vertebrates

51 Environmental risks of biocides | Peter van der Zandt & Paul van der Poel r 50 EU Risk Assessment TGD new version Harmonised Approach to Risk Assessment of New Chem, Existing Chem and Biocides Harmonised Approach to Risk Assessment in the Marine Environment (N.E.B. and OSPAR) Include in Guidance what has been learned in the Existing and New Chemicals areas Include specific guidance for Biocides (i.e. emission scenarios!) Reducing discussion time and disagreements through increasing the extent of guidance http://ecb.jrc.it > documents

52 Environmental risks of biocides | Peter van der Zandt & Paul van der Poel r 51 Revised TGD (2003): relevant exposure assessment issues More complete life cycle assessment Release estimation –emissions from long-life articles –emissions from waste disposal including recovery Unintentional uses: calculation of background concentrations

53 Environmental risks of biocides | Peter van der Zandt & Paul van der Poel r 52 Nice questions! (1) Should the waste stage be included in the exposure assessment of biocides? Yes, the BPD in principle covers also waste stage However the TGD (2003) and the OECD PT8 ESD do not contain models to quantify emissions from waste stage. Relevant assumptions would include (wood preservatives): –how much wood enters the waste stage –how much of that goes to landfill, resp. incineration –how much of the a.i. is still left in the wood –etc..

54 Environmental risks of biocides | Peter van der Zandt & Paul van der Poel r 53 Nice questions! (2) How to use the new (TGD) long-life article emission scenario for wood preservatives and what is the relation to the OECD wood in service scenario? The TGD approach deals with constant emissions over a long time and relates to the regional scale. The OECD scenarios should be followed for wood preservatives. The scenario for wood in service has a different approach. The TGD scenario does not apply for wood preservatives.

55 Environmental risks of biocides | Peter van der Zandt & Paul van der Poel r 54 Nice questions! (3) How should background concentrations and PEC regional be calculated for biocides? Which releases should be taken into account? Biocides emissions generally pertain to local emissions and result in calculations of PEC local. Background concentrations and PEC regional can therefore normally not be determined.


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